Design Quality Engineer III — Medical Device (Onsite — Maple Grove, MN) Contract

Pharmavise Corporation•Maple Grove, MN

9d•Onsite

About The Position

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet client, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, execution and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within the product sustaining group, including Design History File (DHF) remediation and design controls activities to ensure objective evidence is complete, consistent, and inspection-ready.

Requirements

At least 3 years of experience in the Medical Device industry.
Functional understanding of design controls and Design History Files (DHF)
Experience developing, updating, and maintaining Design Input / Output documentation
Functional understanding of risk management documentation, including DFMEA and Hazard Analysis
Applies principles, theories, and concepts to analyze design control issues
Ability to solve complex problems and exercise judgment within defined practices
Ability to plan and organize tasks, schedules, and project priorities
Strong collaboration and communication skills; committed to quality and compliance

Responsibilities

Supports Design History File (DHF) remediation initiatives by assisting with gap assessments, evidence collection, and documentation updates to close design control deficiencies for sustaining products.
Supports remediation planning by helping define scope, assumptions, and acceptance criteria for use of legacy evidence; identifies when additional documentation, review, or testing may be needed and escalates to the remediation lead.
Assists with creating and/or updating DHF content as applicable (e.g., design inputs/outputs, design review documentation, verification/validation evidence mapping, and traceability matrices) in accordance with internal procedures and regulatory requirements.
Leads analysis and proactive upkeep of product risk management tools such as Hazard Analysis and DFMEA, including alignment of risk controls to remediated DHF documentation (inputs/outputs, verification, validation, labeling, and post-market information as applicable).
Supports end-to-end traceability by helping reconcile relationships between design inputs, design outputs, risk controls, verification, and validation; documents discrepancies and supports closure of traceability gaps.
Coordinates with cross-functional partners (e.g., R&D, Manufacturing, RA, Document Control) to route DHF remediation updates for review/approval and ensure documentation is completed, version-controlled, and available within required quality systems.
Supports inspection/audit readiness for remediated DHFs by helping organize objective evidence, preparing summaries of remediation decisions/rationale, and assisting in responses to auditor questions under the direction of the remediation lead.
Acts as an effective team member in supporting quality disciplines, decisions, and practices; may own assigned remediation tasks/deliverables and drive them to closure in alignment with the remediation plan.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including documentation and compliance gaps identified during DHF remediation.
Supports remediation execution by maintaining assigned trackers/records (e.g., gap lists, action items, evidence inventories) and proactively communicating status, risks, and roadblocks to the remediation lead and functional stakeholders.